Group says Abbott committed crime

Data on diet drug Meridia at issue

May 22, 2002|By Bruce Japsen, Tribune staff reporter.

Consumer advocacy group Public Citizen called on the U.S. government to bring criminal charges against Abbott Laboratories, accusing the drugmaker of withholding information from federal officials probing deaths of patients who took the company's diet drug Meridia.

In a letter Tuesday to Health and Human Services Secretary Tommy Thompson, Public Citizen said Abbott illegally withheld information regarding eight patient deaths. The consumer group said one death wasn't reported at all while seven others were reported with inaccurate or incomplete data.

Meridia has come under scrutiny by the Food and Drug Administration and overseas following reports earlier this year of patients dying after taking the medication.

The Italian government suspended Meridia sales after reports of two deaths. Public Citizen in March asked the FDA to ban Meridia, citing 29 deaths and more than 400 adverse patient reactions.

Now, the FDA said it is also investigating Public Citizen's latest complaint that Abbott has not fully disclosed patients' adverse drug experiences with Meridia.

Drug companies are required by law to report adverse effects of their products to the FDA.

"This is very serious," said Dr. Sidney Wolfe, director of Public Citizen's health research group. "We don't do this very often. The evidence for us to even say anything like this is pretty strong."

But Abbott said the charges alleged by Public Citizen and Wolfe are "without merit, are not factual, and have been intentionally written to alarm and mislead physicians and patients."

The North Chicago-based medical products company confirmed a recent audit of the company's Meridia safety database by the FDA's Chicago office and said its responses to the agency have been appropriate.

"The FDA's observations have been fully responded to by Abbott," said John Wolfinger, Abbott's vice president of corporate pharmaceutical quality assurance, in a statement.

Furthermore, Abbott said Public Citizen's allegation of an unreported death "was termed a rumor by the person who contacted the company and was never substantiated."

Abbott said there is no evidence that Meridia caused deaths.

Nearly 9 million people in 70 countries have used Meridia since 1997 and Abbott has stressed that the death rate of users of the drug was less than 1 percent of the mortality normally seen in obese people, who often suffer from other conditions, such as diabetes and heart disease.

Abbott inherited Meridia as part of its acquisition last year of BASF AG's Knoll Pharmaceuticals unit. Meridia's sales were $200 million in 2001, a small fraction of Abbott's nearly $16.3 billion in total revenue. Abbott expects Meridia sales of nearly $400 million this year.